Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011790297

FEI Number

3011790297

Entity Name

DEMCON PRODUCTION B.V.

City/State/Country

Enschede Overijssel, NL

Establishment Address

Institutenweg 50, Enschede Overijssel 7521 PK, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Demcon Production B.V. (Owner Number: 10049517)

Owner / Operator Contact Address

Institutenweg 50, Enschede, NL-OV 7521 PK, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Solar Compact Solar GI with MMS Video option, network and DICOM (VID410, VID625) Solar GI (G3-x) Solar GI with MPP Plus Nexam with MPP Plus Solar GI with CIM-AUX (G3-9, G3-10, G3-15) Ohmega (G2-x) Solar Blue (U3-x) Luna (U5-1) Nexam (U8-x) Finapres NOVA NanoCore Flowmaster (U1-1) Flowstar (U2-1) Finapres NOVA Hemodynamic CNIBPM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2024-09-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-05-27
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2019-05-27
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2019-05-27
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2019-05-27
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2019-05-27
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2019-05-27
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2018-11-29
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2018-11-29
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-11-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-11-29
EXQ	Cystometer, Electrical Recording	Gastroenterology, Urology	Class 2	876.1620	2019-05-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-06-11

Official Correspondent

No official correspondent registered.

US Agent Details

Marissa Theorin Business: ADINSTRUMENTS, INC. Email: a.perado@adinstruments.com Phone: (719) 3060305

Related Public Records

Same Entity

Demcon Production B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3012302888	QUIPMENT INC.	Kennesaw, GA, US
2023374	DIVERSATEK HEALTHCARE INC.	Highlands Ranch, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011790297. Last updated year: 2026. Please use registration number 3011790297 when referencing this establishment in official correspondence.